Botox hits a major wrinkle with lawsuit filed by Hollywood wife
Botox, the drug made famous for its ability to ease a furrowed brow, has a date in court.
On the one side: a glamorous Hollywood fund-raising wife who alleges in a lawsuit that Botox shots caused her to become bedridden with fatigue and her body covered with hives, and her movie-producer husband who contends he has been denied her companionship. On the other side: the Irvine company that developed the immensely popular drug and issued a public statement this week calling the lawsuit frivolous, and a Beverly Hills dermatologist to the stars who also raises funds for charity (including a high-profile event tonight for art and AIDS.)
This is, after all, a town known for celebrity legal cases and needy causes -- and where the “it” treatment for stars attending last year’s Academy Awards was underarm Botox (to prevent sweating) home-delivered by a doctor in a traveling spa dubbed the Botoxmobile.
Filing a lawsuit seeking unspecified amounts in damages are movie mogul Mike Medavoy, 62, chairman and co-founder of Phoenix Pictures and before that with TriStar Pictures and Orion Pictures, and his wife, Irena, who helps run Coach for Kids, which provides free medical care for poor kids.
The defendants are Dr. Arnold W. Klein, whose patients/friends include Elizabeth Taylor, Barry Manilow, Carrie Fisher, Penny Marshall and Michael Jackson (whose ex-wife, Debbie, was Klein’s former nurse), and Allergan Inc., which sells its star product worldwide and says there are no other product liability lawsuits involving Botox.
Botox was first approved by the U.S. Food and Drug Administration in 1989 to treat eye muscle disorders and continued to gain approval for other medically indicated reasons. But when the FDA approved its use for cosmetic purposes last April, it became a staple among the rich, the famous and others unafraid of facial injections.
Botox, Allergan’s name for botulinum toxin Type A, immobilizes muscles in which it is injected, an effect that wears off in three to four months.
The drug is a purified form of the toxin that causes botulism, a potentially fatal form of food poisoning. While in clinical trials for cosmetic use, side effects included headache, respiratory infection, temporary eyelid droop, nausea and flu syndrome. Researchers reported those symptoms were almost always brief.
When used as an age-defying treatment, Botox is typically injected into the muscle just beneath the skin. It is used for frown lines, forehead creases and crows’ feet, although it is officially approved only for use in relaxing the vertical lines between the eyebrows. It is now the fastest growing cosmetic procedure, according to the American Society for Aesthetic Plastic Surgery. The group says more than 1.6 million people had cosmetic Botox injections in 2001, nearly twice as many as the previous year.
The drug is currently the subject of clinical trials for other uses, including control of excessive perspiration and migraine headaches, but is said by many to already be popularly used “off-label” for those purposes.
The power couple
According to the lawsuit filed Jan. 23 in Los Angeles County Superior Court, Irena Medavoy sought treatment last March for migraine headaches and alleges she did not know that receiving face and skull injections was “an off-label use for Botox” or that FDA had not approved Botox’s use for the treatment of migraines. She alleges that Klein failed to disclose the risks of the injection or that it could spread from the point of injection to other parts of her body.
The suit states: “Within several days following the injections, and continuing thereafter for an extended period of time, Irena became and remained extremely ill with severe and unrelenting migraine headaches, upper respiratory problems, fever, weakness, fatigue, severe muscle pain, hives over much of her body and other ailments. Irena was essentially bedridden for a period of many months
Medavoy alleges he has “suffered a reduction or loss of comfort, companionship, intimacy, services, and other valuable aspects of his marital relationship with Irena.”
The lawsuit further alleges that because Klein has served as a consultant to Allergan, Irena was denied “proper independent medical judgment.”
Arthur Leeds, the Medavoys’ attorney, said his clients, parents to a young son, are not ready to talk about the case but dismissed Allergan’s claim that the Medavoys’ lawsuit is frivolous. “It is most definitely not frivolous to Irena and all the other people out there who have to make a decision whether to be using Botox. People who see Irena are going to be surprised by how well she is doing, but those who know her know the difference. She is leading her life as best she can, working with her charities and being with her family, but it takes an enormous toll on her. She pays for it the next day by being stuck in bed with incredible, terrible migraines. But she refuses to be a victim.”
The dermatologist
Call his Beverly Hills office and it may take months to get an appointment. But after you are treated by dermatologist Arnold Klein, chances are he’ll become a pal.
“He’s one of those rare doctors who not only cares about the patient but understands the importance of following up, continuing to have contact, seeing how his patients are,” says Howard Weitzman, Klein’s attorney.
While Botox injections are just one part of Klein’s practice, he is well known for his work with them and lectures extensively on soft tissue augmentation and Botox. The 57-year-old Klein is so sought after and well-liked by the entertainment community that many hopped on board to support a charity event he helped found last year, Art for AIDS, benefiting the AIDS Services Foundation Orange County and the Laguna Art Museum. The second installment of that fund-raiser will be a dinner and auction tonight at the St. Regis Hotel in Dana Point. Many of Klein’s celebrity clients are expected to be there -- last year, Elizabeth Taylor and Michael Jackson were among the guests.
Weitzman has advised Klein not to speak to the media regarding the suit -- “being questioned by the media would fuel the other side,” the Century City lawyer said.
Weitzman doesn’t expect the lawsuit to affect Klein professionally. “But I think it’s a big blow to him personally. Botox is a transitory medicine that is a safe and recognized treatment for a number of symptoms. I believe the treatment Dr. Klein provided Mrs. Medavoy, a patient of his for many years, was well within established medical guidelines and Mrs. Medavoy’s continuing illnesses are not a result of her voluntary use of Botox.”
The company
On Tuesday, 12 days after the Medavoys filed their lawsuit, Allergan released a statement that read, in part: “We intend to aggressively defend our product in court and do not intend to resolve this matter short of complete vindication.”
The company, founded in 1950 and named for its first product, allergy nose drops, said Botox is approved for use in 70 countries for the treatment of a wide range of conditions, including crossed eyes and uncontrollable blinking.
Botox is Allergan’s best selling product. Research for new ways to use it is ongoing, including the clinical trials for treating migraines. Allergan spokeswoman Christine Cassiano said this week that Klein is not part of that study but, like all doctors, can use approved drugs for indications beyond those listed on the label if he sees benefit for a patient in doing so.
Allergan attorney Douglas Ingram says Botox has an “enormously impressive record” stretching back 20 years and has been used on millions of patients. He says that the “claims of Mrs. Medavoy are inconsistent with how Botox works” because the drug is injected locally and its effects wear off.
Last year, sales of Botox reached $439.7 million, compared with $311 million the year before. Today, about 60% of Botox sales are for medically indicated uses; about 40% for cosmetic ones.
If the lawsuit proceeds as expected, the parties will have their day in court on June 24 at Superior Court in Santa Monica.